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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K864472
Device Name PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK
Applicant
Tagg Industries
Division Of Gsa
15791 Rockfield Blvd. Unit D
Irvine,  CA  92718
Applicant Contact GEORGE W ATCHLEY,JR
Correspondent
Tagg Industries
Division Of Gsa
15791 Rockfield Blvd. Unit D
Irvine,  CA  92718
Correspondent Contact GEORGE W ATCHLEY,JR
Regulation Number868.5870
Classification Product Code
CBP  
Date Received11/13/1986
Decision Date 01/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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